Agitation has been fermenting since early February, when agency director Elias A. Zerhouni imposed the rules after a congressional committee found that about 120 NIH scientists had not disclosed outside consulting deals, as required. Less than a month later, the NIH acknowledged that most of the researchers had been unfairly accused because of agency clerical errors.
"That's the sad reality of the whole thing. . . . A few people ruined it for everyone," said Ashani Weeraratna, a cancer researcher who was told that she could not accept a $200 train ticket from a physician's education group to present a paper at a conference in New York.
"I was like, 'What?' " Weeraratna said. "I felt awful. I had to call and tell them to find someone else. It was embarrassing." The rules are meant to guard against potential conflicts between public and commercial science, but NIH researchers said the requirements harshly upend the unique -- and they contend productive -- collaborative environment that has evolved at NIH alongside the biotech industry. NIH and industry experts said that since the new rules were announced, agency researchers have been backing away from consulting deals that, while helpful to drug and biotech companies, also gave scientists insight into the application of their work.
Though a few researchers collected hundreds of thousands of dollars in consulting fees, most arrangements involved a few days of service for less than $10,000 and occasionally stock options -- which helped keep researchers at NIH despite salaries far less than they could earn elsewhere. Junior researchers might enter NIH earning $40,000 annually, but they had the prestige of working at a renowned institution alongside the best in the field and could look forward to a career in which they could also dabble in the commercial world. The relationships are vital throughout the drug industry and are especially important to Montgomery County, where officials tout the NIH's presence when attempting to woo biotech companies. NIH researchers often work closely with area firms, and some have launched businesses with the help of local venture capitalists.
"A lot of these researchers really want to understand the commercial side of their work," said Jerry Feigen, former director of the Macklin Center for Entrepreneurship at Montgomery College, who teaches a business class at NIH that features lectures by local venture investors.
"If the NIH wants to land the brightest brains, they have to come to grips with helping do-good researchers understand the commercial side of science," Feigen said. "I don't think there's anything wrong with that."
Agency officials said classes like Feigen's will continue and argue that concerns about the impact on private industry are somewhat exaggerated. Researchers can still work with companies as part of their official NIH duties, particularly under agreements in which each side provides resources to develop products.
And NIH employees will still be entitled to up to $150,000 a year in royalties if companies license their discoveries and develop a product. MedImmune Inc., one of Maryland's most successful biotechs, developed Synagis, a billion-dollar product, this way.
But researchers said the restrictions have already chilled interactions that advance scientific know-how, and they are irritated by having to end relationships with scientific organizations. Under the new rules, many NIH employees cannot hold executive positions -- even on a volunteer basis -- with trade or professional organizations, because those groups often represent scientists who could be grant recipients. They also cannot accept awards or prizes of more than $200.
Robert L. Nussbaum, chief of the Genetic Disease Research Branch, said he is applying for a waiver so he can continue his unpaid position as past president of the American Society of Human Genetics. Even if the agency allows it, he worries that organizations will shy away from NIH researchers.
"But what I'm really worried about is backlash from the organizations," he said. "They'll think it will be too much trouble to get us. We will be cut off, disenfranchised from our academic colleagues."
Several organizations, including the American Association of Immunologists and the Federation of American Societies for Experimental Biology, have written to Health and Human Services Department officials expressing concern over the restrictions.
AAI urged that the rules be immediately withdrawn and expressed concern about the agency's ability to attract and retain top scientists -- a fear embodied in the recent departures of senior staffers such as National Cancer Institute pathologist Lance A. Liotta.
Liotta, who is starting a research center at George Mason University, declined to comment. He was among those highlighted by congressional investigators for consulting deals. Vikas Chandhoke, George Mason's associate dean for research, would not address Liotta's reasons for leaving NIH but said, "I don't think it will be attractive for researchers to work in restrictive environments."
Researchers at George Mason, like those at many other academic institutions, are encouraged to consult with private companies, he said. They can do so one day a week, with no cap on how much they can earn.
Margaret L. Kripke, chief academic officer for the M.D. Anderson Cancer Center in Houston, an organization that frequently recruits at NIH, said researchers there can earn an additional 50 percent of their annual salaries from consulting agreements. "It puts our physicians on the front lines of new drugs being developed that we can make available to our patients," she said. "We strongly encourage them to consult."
Kripke said: "It may not be quite as difficult to recruit at NIH as it has been in the past. The NIH is not a very happy place these days."